Epoetin Alfa

Epogen stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.

• Epogen is an erythropoiesis-stimulating agent (ESA) indicated for: Treatment of anemia due to: - Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). - Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ).ICD-10: B20, D64.9, N18.9

• Epogen is contraindicated in patients with: Uncontrolled hypertension [see Warnings and Precautions ( 5.3 )] Pure red cell aplasia (PRCA) that begins after treatment with Epogen or other erythropoietin protein drugs [see Warnings and Precautions ( 5.6 )] Serious allergic reactions to Epogen [see Warnings and Precautions ( 5.7 )] Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in: Neonates, infants, pregnant women, and lactating women [see Warnings and Precautions ( 5.9 ), Use in Specific Populations ( 8.1 , 8.2 , 8.4 )] .contraindicated

Evaluate iron status before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia before initiating treatment ( 2.1 ). In pregnant women, lactating women, neonates, infants: Use only single-dose vials ( 2.1 ). Patients with CKD: Initial dose: 50 to 100 Units/kg 3 times weekly (adults) and 50 Units/kg 3 times weekly (pediatric patients). Individualize maintenance dose. Intravenous route recommended for patients on hemodialysis ( 2.2 ). Patients on Zidovudine due to HIV infection: 100 Units/kg 3 times weekly ( 2.3 ). Patients with Cancer on Chemotherapy: 40,000 Units weekly or 150 Units/kg 3 times weekly (adults); 600 Units/kg intravenously weekly (pediatric patients ≥ 5 years) ( 2.4 ). Surgery Patients: 300 Units/kg per day daily for 15 days or 600 Units/kg weekly ( 2.5 ). 2.1 Important Dosing Information Evaluation of Iron Stores and Nutritional Factors Evaluate the iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Monitoring of Response to Therapy Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Epogen. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion.

Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit ( 5.1 and 14.1 ). Use caution in patients with coexistent cardiovascular disease and stroke ( 5.1 ). Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer ( 5.2 ). Hypertension: Control hypertension prior to initiating and during treatment with Epogen ( 5.3 ). Seizures: Epogen increases the risk for seizures in patients with CKD ( 5.4 ). Increase monitoring of these patients for changes in seizure frequency or premonitory symptoms ( 5.4 ). PRCA: If severe anemia and low reticulocyte count develop during Epogen treatment, withhold Epogen and evaluate for PRCA ( 5.6 ). Serious Allergic Reactions: Discontinue Epogen and manage reactions ( 5.7 ). Severe Cutaneous Reactions: Discontinue Epogen ( 5.8 ). 5.1 Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 – 14 g/dL) to lower targets (9 - 11.3 g/dL), Epogen and other ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups.

The following serious adverse reactions are discussed in greater detail in other sections of the label: Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see Warnings and Precautions ( 5.1 )] Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Seizures [see Warnings and Precautions ( 5.4 )] PRCA [see Warnings and Precautions ( 5.6 )] Serious Allergic Reactions [see Warnings and Precautions ( 5.7 )] Severe Cutaneous Reactions [see Warnings and Precautions ( 5.8 )] Patients with CKD: Adverse reactions in ≥ 5% of Epogen-treated patients in clinical studies were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection ( 6.1 ). Patients on Zidovudine due to HIV infection: Adverse reactions in ≥ 5% of Epogen-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation ( 6.1 ). Patients with Cancer on Chemotherapy: Adverse reactions in ≥ 5% of Epogen-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis ( 6.1 ). Surgery Patients: Adverse reactions in ≥ 5% of Epogen-treated patients in clinical studies were nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension ( 6.1 ).

8.1 Pregnancy Risk Summary Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in pregnant women [see Contraindications ( 4 )] . When therapy with Epogen is needed during pregnancy, use a benzyl alcohol-free formulation (i.e., single-dose vial). Do not mix Epogen with bacteriostatic saline when administering to pregnant women because it contains benzyl alcohol ( see Clinical Considerations ) [see Dosage and Administration ( 2.1 ) ] . The limited available data on Epogen use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproductive and developmental toxicity studies, adverse fetal effects including embryo-fetal death, skeletal anomalies, and growth defects occurred when pregnant rats received epoetin alfa at doses approximating the clinical recommended starting doses ( see Dat a) . Consider the benefits and risks of Epogen single-dose vials for the mother and possible risks to the fetus when prescribing Epogen to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

In adult and pediatric patients with CKD, the elimination half-life (t 1/2 ) of plasma erythropoietin after intravenous administration of Epogen ranged from 4 to 13 hours. After subcutaneous administration, C max was achieved within 5 to 24 hours.

Epogen overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Epogen dosage and/or with phlebotomy, as clinically indicated [see Clinical Pharmacology ( 12.2 )] . Cases of severe hypertension have been observed following overdose with ESAs [see Warnings and Precautions ( 5.3 )] .

• Jun 1, 1989BLABLA103234Amgen
• May 15, 2018BLABLA125545Hospira Inc

1. 1Product Storage Error1,1368.2%
2. 2Death9276.7%
3. 3Anaemia8616.2%
4. 4Off Label Use8266.0%
5. 5Haemoglobin Decreased7675.6%
6. 6Dyspnoea6764.9%
7. 7Nausea6504.7%
8. 8Diarrhoea6194.5%
9. 9Pain5824.2%
10. 10Asthenia5724.1%
11. 11Vomiting5654.1%
12. 12Circumstance Or Information Capable Of Leading To Medication Error5484.0%
13. 13Nephrogenic Systemic Fibrosis5303.8%
14. 14Fatigue5063.7%
15. 15Hypotension4753.4%

Recent PubMed references pinned to Epoetin Alfa as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• A Rising Cluster of Erythropoietin-Associated Pure Red Cell Aplasia and Subsequent Response to Roxadustat: A Case Series.
  Nephrology (Carlton, Vic.) · 2026 · Devathasan J, Goh TL, Lin DC, et al.
  PMID 41601277DOI 10.1111/nep.70169
• An analysis of cost-saving in the German statutory health insurance system due to the introduction of epoetin alfa biosimilars in Germany.
  Frontiers in public health · 2025 · Raitner I, Müller B, Vijayan A, et al.
  PMID 41477238DOI 10.3389/fpubh.2025.1667315
• Reference Standard Calibration Challenges in the Case of Erythropoietin: Impact on Potency and Biosimilarity Determination.
  The AAPS journal · 2025 · TerWee J, Wilson-Landy K, Wang Y, et al.
  PMID 41350961DOI 10.1208/s12248-025-01175-x
• Impact of intravenous iron or exogenous erythropoietin on hemoglobin mass, exercise performance, and acute mountain sickness during altitude acclimatization.
  Journal of applied physiology (Bethesda, Md. : 1985) · 2025 · Bradbury KE, Gideon EA, Baranauskas MN, et al.
  PMID 40912897DOI 10.1152/japplphysiol.00076.2025
• Long-Term Transfusion Independence with Luspatercept Versus Epoetin Alfa in Erythropoiesis-Stimulating Agent-Naive, Lower-Risk Myelodysplastic Syndromes in the COMMANDS Trial.
  Advances in therapy · 2025 · Garcia-Manero G, Santini V, Zeidan AM, et al.
  PMID 40377899DOI 10.1007/s12325-025-03208-5
• Comparative efficacy of epoetin alfa vs. darbepoetin in children with chronic kidney disease: a systematic review, meta-analysis and cost-effectiveness analysis.
  Journal of nephrology · 2025 · Bertazza Partigiani N, D'Uva A, Vigezzi S, et al.
  PMID 40349276DOI 10.1007/s40620-025-02303-8
• Epoetin alfa has a potent anxiolytic effect on naive female rats.
  BMC pharmacology & toxicology · 2025 · Çalışkan H, Koçak S, Güneş E, et al.
  PMID 39876022DOI 10.1186/s40360-025-00845-y
• Initial experiences with combined therapy of anemia with roxadustat and epoetin α in hemodialysis patients: a case series.
  Polish archives of internal medicine · 2024 · Biedunkiewicz B, Jankowska M, Komorniczak M, et al.
  PMID 39315513DOI 10.20452/pamw.16846

The 10 most recently updated of 656 ClinicalTrials.gov registrations naming Epoetin Alfa as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers
  Completed · Interventional · 14 enrolled · Rennes University Hospital
  NCT00687518updated 2026-06-12
• MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
  Recruiting · Phase 2 · Interventional · 2,000 enrolled · National Cancer Institute (NCI)
  NCT05564390updated 2026-06-11
• Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage
  Recruiting · Phase 1 · Interventional · 60 enrolled · Johns Hopkins University
  NCT05617833updated 2026-06-10
• Luspatercept vs Epoetin in Treating Poor Erythroid Engraftment for Hematological Malignancies
  Not yet recruiting · Phase 2 · Phase 3 · Interventional · 90 enrolled · Nanfang Hospital, Southern Medical University
  NCT07636486updated 2026-06-09
• Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia
  Active not recruiting · Phase 3 · Interventional · 247 enrolled · National Cancer Institute (NCI)
  NCT00843882updated 2026-05-29
• Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
  Recruiting · Phase 2 · Interventional · 120 enrolled · University of Washington
  NCT05340465updated 2026-05-26
• A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
  Recruiting · Phase 3 · Interventional · 429 enrolled · Genexine, Inc.
  NCT06466785updated 2026-05-22
• Effect of Single vs Repeated Cycles of a Combination of Granulocyte Colony Stimulating Factor and Darbepoetin vs Standard Medical Treatment on Immunometabolic Profile in Patient With Early Decompensated Cirrhosis.
  Recruiting · Interventional · 60 enrolled · Institute of Liver and Biliary Sciences, India
  NCT07002827updated 2026-05-22
• A Trial Comparing Three Different Treatment Options for Adults With Low-Risk Myelodysplasia and Anemia (A MyeloMATCH Treatment Trial)
  Not yet recruiting · Phase 2 · Interventional · 270 enrolled · National Cancer Institute (NCI)
  NCT07463820updated 2026-05-13
• Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite Athletes
  Enrolling by invitation · Interventional · 60 enrolled · Enhanced Emirates Limited
  NCT07568574updated 2026-05-06

Frequently asked questions

How does Epoetin Alfa work?

Epogen stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.

What is Epoetin Alfa used for?

According to FDA labeling, Epoetin Alfa carries indications including: Epogen is an erythropoiesis-stimulating agent (ESA) indicated for: Treatment of anemia due to: - Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). - Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Epoetin Alfa?

Epoetin Alfa is classified as Erythropoiesis-stimulating Agent, Increased Blood Pressure, Increased Erythroid Cell Production.

What are the brand names for Epoetin Alfa?

Epoetin Alfa is marketed under brand names including Epogen, Procrit, Retacrit.

What are the contraindications for Epoetin Alfa?

Epoetin Alfa labeling lists contraindications including: Epogen is contraindicated in patients with: Uncontrolled hypertension [see Warnings and Precautions ( 5.3 )] Pure red cell aplasia (PRCA) that begins after treatment with Epogen or other erythropoietin protein drugs [see Warnings and Precautions ( 5.6 )] Serious allergic reactions to Epogen [see Warnings and Precautions ( 5.7 )] Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in: Neonates, infants, pregnant women, and lactating women [see Warnings and Precautions ( 5.9 ), Use in Specific Populations ( 8.1 , 8.2 , 8.4 )] .. Always consult the full prescribing information and a clinician.